Inlyta (axitinib)

Inlyta tablets contain the active ingredient axitinib, which is a type of medicine known as a protein kinase inhibitor. It works by interfering with the pathways that signal certain cancer cells to grow.

What is it used for?

Axitinib is licensed to treat advanced kidney cancer that has not responded to treatment with sunitinib or cytokine therapy, for example aldesleukin or interferon alfa.

How does it work?

Inlyta tablets contain the active ingredient axitinib, which is a type of medicine known as a protein kinase inhibitor. It works by interfering with the pathways that signal certain cancer cells to grow.

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The way that cells in the body work and grow is regulated by various enzymes called protein kinases. These enzymes can be found in certain receptors on the surface of cells that are involved in the growth and spread of cancer cells.

In cancerous cells, the kinases make the cells grow and multiply abnormally. They also stimulate nearby blood vessels to grow into the tumour. The new blood vessels allow the cancer cells to grow and multiply by supplying them with oxygen and nutrients. They also allow the cancerous cells to spread into other areas of the body through the blood circulation.

Tumours have been found to produce a particular growth factor called vascular endothelial growth factor (VEGF). VEGF stimulates new blood vessels to grow into the tumour.

Axitinib works by attaching to VEGF receptors on the cancer cells and blocking the action of the protein kinase enzymes. This stops the signals that tell the cancer cells to grow and multiply. It also stops blood vessels growing into the tumour. This reduces the tumour’s blood supply and with it, its supply of oxygen and nutrients. Both these effects slow down or stop the growth and spread of the tumour cells.

How do I take it?

Inlyta tablets should be taken twice a day, at the same times each day (approximately 12 hours apart). Swallow the tablets whole with a glass of water; do not break, crush or chew them. The tablets can be taken either with or without food.

The dose of this medicine may be started low and increased gradually. It may be adjusted if you experience certain side effects or take certain other medicines. It is important to follow the instructions given by your doctor. Your doctor will usually ask you to keep taking this medicine for as long as it continues to work, as long as it is not causing unacceptable side effects.

If you forget to take a dose at your normal time, just skip that dose and take your next dose as usual. Do not take a double dose to make up for a missed dose.

You should avoid drinking grapefruit juice or eating grapefruit while taking this medicine, as it may increase the level of this medicine in your blood and hence increase the risk of side effects.

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Warning!

This medicine can cause your thyroid gland to become overactive or underactive. You will need to have a blood test to check the levels of thyroid hormones in your blood (thyroid function tests) before starting treatment and regularly throughout treatment.

Your doctor will need to regularly check your blood pressure and levels of protein in your urine while you are having treatment with this medicine. If your blood pressure rises too much you may need extra medicines to control it. If it can’t be controlled your treatment may need to be stopped temporarily.

Your doctor will also need to check your liver function before starting this medicine and regularly while you continue to take it.

This medicine may decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you may need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.

This medicine may increase the risk of bleeding. You should tell your doctor or nurse if you notice any bleeding, for example nosebleeds, bleeding gums, blood in your urine, vomiting blood, coughing up blood, or passing black/tarry/blood-stained stools.

This medicine can also affect wound healing. It is important that you tell any health professional treating you, including your dentist, that you are having treatment with this medicine. If you are due to have any surgery it is also important to talk to your doctor in advance, as treatment with this medicine needs to be stopped at least 24 hours before surgery.

There may be an increased risk of developing a blood clot in a vein (DVT or pulmonary embolism) or a blood clot in an artery (which could cause a heart attack or stroke) while having treatment with this medicine. For this reason, you should let your doctor know immediately if you get any of the following symptoms during treatment: stabbing pains and/or unusual swelling in one leg, pain on breathing or coughing, coughing up blood, sudden breathlessness, sudden severe chest pain, sudden disturbance in vision, hearing or speech, sudden weakness or numbness on one side of the body, fainting or collapse.

This medicine may affect your ability to get pregnant or father a child. It is important to discuss fertility with your doctor before treatment with this medicine is started.

This medicine may also be harmful to an unborn baby. For this reason, women receiving this medicine should use an effective method of contraception to prevent pregnancy, both during treatment and for at least one week after treatment is finished. You should consult your doctor immediately if you think you could be pregnant.

The safety and efficacy of this medicine have not been established in children and adolescents under 18 years of age. It is not recommended for this age group.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

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This medicine must not be used during pregnancy unless considered essential by your doctor. It could be harmful to a developing baby because it stops the formation of new blood vessels. Women who could get pregnant must use effective methods of contraception to prevent pregnancy while having treatment with this medicine and for at least one week after the treatment is finished. Seek medical advice from your doctor. Inform your doctor immediately if you think you could be pregnant at any point during treatment.

It is not known if this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed, because if the medicine does pass into the breast milk it could be harmful to a nursing infant. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

Underactive thyroid gland (hypothyroidism).

Loss of appetite and weight loss.

Headache.

Change in taste.

Raised blood pressure (hypertension).

Change in voice.

Bleeding - see warning section above.

Feeling or being sick.

Diarrhoea.

Constipation.

Inflammation of the mouth (stomatitis).

Painful redness, swelling, blistering or ulceration of the palms and soles (hand-foot syndrome or palmar-plantar erythrodysesthesia).

Skin reactions such as dry skin, itching or rash.

Protein in the urine.

Feeling weak or tired.

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Common (affect between 1 in 10 and 1 in 100 people)

Decrease in the number of red blood cells or platelets in the blood (anaemia or thrombocytopenia - see warning section above).

Dehydration.

Dizziness.

Sensation of ringing or other noise in the ears (tinnitus).

Cough.

Feeling short of breath.

Sore throat.

Indigestion or stomach ache.

Flatulence (wind).

Piles (haemorrhoids).

Skin reactions such as redness or itching.

Hair loss.

Aching joints and muscles.

Kidney failure.

Increased levels of liver enzymes.

Blood clot in a vein of the leg or in the lungs (deep vein thrombosis or pulmonary embolism) - see warning section above.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Increased levels of potassium and calcium in the blood (hyperkalaemia and hypercalcaemia).

Development of an abnormal hole in the gut. Signs may include stomach pain, being sick, fever or chills. Tell your doctor if you get these symptoms.

Development of a fistula, which is an abnormal connection or passageway inside the body between internal organs and skin or other tissues, for example between the gut and the skin.

Nerve disorder known as posterior reversible encephalopathy syndrome. Signs may include headache, feeling sick or vomiting, sight changes, feeling confused or fits. Tell your doctor if you get these symptoms.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

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For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

You should tell your doctor or pharmacist if you are taking any other medicines, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, you should also check with your doctor or pharmacist before taking any new medicines while you are still receiving treatment with this medicine, so they can check that the combination is safe.

The medicines listed below are strong inhibitors of the enzyme in the liver that breaks down axitinib. They may increase the blood level of axitinib, which could increase the risk of its side effects. These are not recommended for people taking this medicine. If any of these medicines prove to be essential, your doctor may need to decrease your dose of axitinib while you are taking the combination:

The following medicines may increase the breakdown of axitinib by the body and so could decrease the amount of axitinib in the blood, making it less effective. These should be avoided where possible while you are taking axitinib, but if they can’t be avoided your doctor may need to increase your dose of axitinib while you are on the combination:

carbamazepine

dexamethasone

phenytoin

phenobarbital

rifabutin

rifampicin

the herbal remedy St John's wort (Hypericum perforatum).

This medicine can decrease the body's immune response. This means that vaccines may be less effective if given during treatment, because the body does not produce sufficient antibodies. Live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, BCG, chickenpox, oral polio, oral typhoid and yellow fever. These should not be given to people whose immune system is underactive due to treatment with this medicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain axitinib as the active ingredient.

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